Fiscal Year 2020

CERTIFICATION OF REGISTRATION
This certifies that:

TANGSHAN UMG MEDICAL INSTRUMENT CO., LTD.

Room328, Block C, Teachers College Center For Iternational
Exchange, High-tech District, Tangshan, China

has completed the FDA Establishment Registration (as manufacturer, contract

manufacturer) and Device Listing with the US Food & Drug Administration, through

U.S. Agent for FDA SUNGO TECHNICAL SERVICE INC.

Communications: 6050 W EASTWOOD AVE APT 201, CHICAGO,
ILLINOIS 60630, USA
Telephone: +1-855-957-7779 / E-mail: sungo.group@yahoo.com

Registration Number: 3012441973

Device Listing#: See annex

SUNGO Technical Service Inc. will confirm that such registration remains effective upon request and
presentation of this certificate until the end of the calendar year stated above, unless said registration is
terminated after issuance of this certificate. SUNGO Technical Service Inc. makes no other
representations or warranties, nor does this certificate make any representations or warranties to any
person or entity other than the named certificate holder, for whose sole benefit it is issued. This
certificate does not denote endorsement or approval of the certificate-holder’s device or establishment
by the U.S. Food and Drug Administration. SUNGO Technical Service Inc. assumes no liability to any
person or entity in connection with the foregoing.

Pursuant to 21 CFR 807.39, “Registration of a device establishment or assignment of a registration

number does not in any way denote approval of the establishment or its products. Any representation
that creates an impression of official approval because of registration or possession of a registration
number is misleading and constitutes misbranding.” The U.S. Food and Drug Administration does not
issue a certificate of registration, nor does the U.S. Food and Drug Administration recognize a
certificate of registration, SUNGO Technical Service Inc. is not affiliated with the U.S. Food and Drug
Administration.

Executive Director
Issued: Dec. 27 2019
Cert. No.: 2006US111548
Expiration Date: Dec. 31 2020

SUNGO CHINA OFFICE Tel: 021-68828052 Email:Shage2008@126.com Website: www.sungoglobal.com

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Add: 13 Floor, No.1500 Century Avenue, Shanghai 200122, P.R.China
 Fiscal Year 2020
CERTIFICATION OF REGISTRATION
Annex to Cert. No.: 2006US111548
Listing No Code Device Name
CHAIR, DENTAL, WITHOUT OPERATIVE UNIT
D253785 NRU
(Dental Patient Chairs & Stool)
DILATOR, NASAL
D253786 LWF
(Snore Stopper)
HANDPIECE (BRACE), DRILL
D253787 HBD
(Handpiece)
FLOSS, DENTAL
D253788 JES
(Dental Floss)
ERASER, DENTAL STAIN
D253789 MAU
(Teeth Whitening Cleaning Kit)
CLEANSER, DENTURE, OVER THE COUNTER
D253790 EFT
(Denture Cleaning Tablet)
APPLICATOR, ABSORBENT TIPPED, NON-STERILE
D253799 KXF
(Micro Applicator)
BRUSH, DERMABRASION, MANUAL
D253800 GED
(Brush Applicator)
HANDLE, INSTRUMENT, DENTAL
D253801 EJB (Mixing Rod & Well, Dental Disposable Cartridge Syringe; Poly,
Wooden Wedge)
SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
D253802 EID
(HP Intra-Oral Tips)
AID, TRANSFER
D253803 IKX
(Cotton Roll Dispenser)
COTTON, ROLL
D253804 EFN
(Cotton Roll)
TRAY, IMPRESSION, PREFORMED
D253805 EHY
(Impression Tray, EHY Tray Base)
SHIELD, EYE, RADIOLOGICAL
D253806 IWS
(Protective Safety Glass)
SHIELD, PROTECTIVE, PERSONNEL
D253807 KPY
(Face Shield With Frame)
SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY
D253808 GAF
(Spatula)
MOUTHPIECE, SALIVA EJECTOR
D253809 DYN
(Saliva Ejector)

SUNGO CHINA OFFICE Tel: 021-68828052 Email:Shage2008@126.com Website: www.sungoglobal.com

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Add: 13 Floor, No.1500 Century Avenue, Shanghai 200122, P.R.China
 Fiscal Year 2020
CERTIFICATION OF REGISTRATION
Annex to Cert. No.: 2006US111548
Listing No Code Device Name
EVACUATOR, ORAL CAVITY
D253810 EHZ
(Oral Evacuator, EHZ Surgical Aspirator Tips)
CONTAINER, LIQUID MEDICATION, GRADUATED
D253811 KYW
(Dental Material Bottle & Dishes)
DISPENSER, LIQUID MEDICATION
D253812 KYX
(Composite Dispensing Gun With Plastic Tip, Impression Gun)
PATIENT PERSONAL HYGIENE KIT
D253813 NSB (Dental Instrument Storage Box Cassette; Dental Instrument
Kits(Including: Tweezers, Probe, Dental Mirror))
MIRROR, MOUTH
D253814 EAX
(Dental Mouth Mirror)
PROBE, PERIODONTIC
D253815 EIX
(Dental Probe)
FORCEPS, TOOTH EXTRACTOR, SURGICAL
D253818 EMG
(Dental Forceps)
HOLDER, FILM, X-RAY
D253819 EGZ
(X-Ray Film Holder X)
TRAY, SURGICAL, INSTRUMENT
D253820 FSM
(Medical Instrument Tray; Storage Cassette)
UNIT, SYRINGE, AIR AND/OR WATER
D253821 ECB
(Curved Utility Syringes)
CARRIER, AMALGAM, OPERATIVE
D253822 EKI
(Amalgam Carrier)
ADAPTOR, HYGIENE
D253823 ILS
(Dental Bib Pin, ILS Dental Bib, Denture Box)
MASK, SCAVENGING
D253824 KHA
(Safe Mask, Isolation Mask)
DRESS, SURGICAL
D253825 FYE
(Surgical Gown(No-Woven))
CAP, SURGICAL
D253826 FYF
(Doctor Cap)
COVER, SHOE, OPERATING-ROOM
D253829 FXP
(Shoe Covers)
NEEDLE, DENTAL
D253830 DZM
(Dental Needle)

SUNGO CHINA OFFICE Tel: 021-68828052 Email:Shage2008@126.com Website: www.sungoglobal.com

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Add: 13 Floor, No.1500 Century Avenue, Shanghai 200122, P.R.China
 Fiscal Year 2020
CERTIFICATION OF REGISTRATION
Annex to Cert. No.: 2006US111548
Listing No Code Device Name
INSTRUMENTS, DENTAL HAND
D253831 DZN (Endo Measuring Block, Air Water Syringe Tip, DZN Mixing
Tip, Silicone Rubber Cup)
ACCESSORIES, RETRACTOR, DENTAL
D253832 EIF
(Bur Holder, Rubber Dam/Mouth Gag, Cheek Retractor)
UNIT, OPERATIVE DENTAL, ACCESSORIES
D253833 NRD
(Dental Sleeves, Universal Barrier Film)
POINT, ABRASIVE
D253834 EHL
(Dental Prophy Angle Brush Cup)
BUR, DENTAL
D253836 EJL
(Bur; Bur, Inter-ProximalReduction (IPR) Instrument)
DENTAL HYGIENE KIT
D253838 NXZ
(Dental Flushing Suite)
DENTAL IMPLANT SURGICAL TRAY
D253839 OFY (Orthodontic Kit (Including Toothbrush, Orthodontic Wax, Timer,
Dental Mirror, Dental Floss, Thread))
DEVICE, PATIENT TRANSFER, POWERED
D283895 FRZ
(Intelligent Patient Transfer Nursing Robot Bed)
HEAT SOURCE FOR BLEACHING TEETH
D283896 EEG
(Curing Light)
CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR
D283897 JQC CLINICAL USE
(Centrifuge)
PROTECTOR, DENTAL
D312194 BRW
(Dental Guard, Mouthguard)
INSTRUMENT, CONTOURING, MATRIX, OPERATIVE
D312195 EKF
(Dental Automatic Matrix Kit (Matrix, Forceps))
Accessories, implant, dental, endosseous
D338484 NDP
(Education Model)
GUTTA-PERCHA
D338485 EKM
(Gutta-Percha)
FILE, PULP CANAL, ENDODONTIC
D338486 EKS
(Root Canal Files)
UNIT, ORAL IRRIGATION
D366913 EFS
(Water Flosser)
LOUPE, DIAGNOSTIC/SURGICAL
D366914 FSP
(Dental Loupe)
POST, ROOT CANAL
D366915 ELR
(Screw Post)
PAPER, ARTICULATION
D366916 EFH
(Articulating Paper)
END OF THE ANNEX
SUNGO CHINA OFFICE Tel: 021-68828052 Email:Shage2008@126.com Website: www.sungoglobal.com
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Add: 13 Floor, No.1500 Century Avenue, Shanghai 200122, P.R.China